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Diet, Other Risk Factors, Genetics and the Risk of Colorectal Neoplasia in a Screening Trial of Asymptomatic Women: A Sub-Study of the CONCeRN Trial

40 Years
79 Years
Not Enrolling
Colorectal Neoplasia

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Trial Information

Diet, Other Risk Factors, Genetics and the Risk of Colorectal Neoplasia in a Screening Trial of Asymptomatic Women: A Sub-Study of the CONCeRN Trial

The CONCeRN Trial is a multi-center study of asymptomatic women between the ages of 40 and
75 referred to regional military medical centers for routine colorectal screening. The
primary purpose of the main study is to determine the extent to which advanced neoplastic
lesions will be missed if clinicians only perform sigmoidoscopies rather than full
colonoscopies as a screening procedure and to resolve current debate about the significance
of sigmoidoscopic detection of single, small, tubular adenomas (i.e., do they imply greater
risk for large adenomatous polyps or colorectal cancer at other sites beyond the reach of
the sigmoidoscope, or is there no increased risk?). Women enrolled in the trial receive
colonoscopy during which all identified polyps are removed and also during which two pinch
biopsies of apparently-normal tissue are taken. In addition, before the colonoscopy is
performed, patients will have blood drawn and answer a brief questionnaire on risk factors
for colorectal cancer. The NCI-led sub-study added a more extensive questionnaire to assess
dietary and other lifestyle factors potentially related to colorectal cancer, and obtained
additional blood for assessment of nutritional status and for analysis of genetic
polymorphisms related to colorectal cancer. With the additional information available from
these questionnaires and blood samples, it will be possible to explore the extent to which
various dietary and genetic risk factors are related to colorectal polyps in asymptomatic
women of average risk for disease. Recruitment is now complete at all sites. A total of
937 women were recruited. Of these, about one-quarter of the women with one or more
adenomas had an advanced adenoma, defined as being greater than or equal to 1 cm in
diameter, or having high grade dysplasia or villous elements). These neoplasia prevalence
figures are in line with initial projections. Active contact with participants is
concluded. We have now entered into a data analysis phase.

Inclusion Criteria


50-79, asymptomatic women of average risk referred for colorectal screening.

40-79 year-old asymptomatic women referred for colorectal screening with a history of
colorectal cancer in a first degree relative.


History of positive stool guiaic within six months of referral.

History of iron deficiency anemia within six months of referral (Note: if patients have
not had stool guiacs, complete blood cell count or ferritin performed within the last six
months, then these tests will be performed at time of study enrollment).

History of normal colonoscopy or barium enema within past ten years or history of normal
flexible sigmoidoscopy within past 5 years.

History of adenomatous polyps, colorectal cancer, inflammatory bowel disease, HNPCC, or
familial adenomatous polyposis.

History of rectal bleeding or hematochezia within the past 12 months.

Unintentional weight loss greater than 10 pounds within previous six months.

Pregnant women.

Subjects under 18 years of age.

Type of Study:


Study Design:


Principal Investigator

Amanda J Cross, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2000

Completion Date:

Related Keywords:

  • Colorectal Neoplasia
  • Polyp
  • Diet
  • Nutrition
  • Polymorphism
  • Cooking
  • Neoplasms



National Naval Medical Center Bethesda, Maryland  20889
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Naval Medical Center, San Diego San Diego, California  92134-5000